Biologics

FDA Promoting Blood Pathogen Reduction Means

FDA commissioner Scott Gottlieb and CBER director Peter Marks say the agency is seeking better safety measures to mitigate potential risks to blood products. In a joint statement, they say that technology exists to potentially transform the assurance of blood product safety while also potentially reducing the cost.

Whether an existing technology can be advanced to fully meet an ideal of a pathogen reduction technology that is relatively inexpensive, simple to implement on whole blood, and would allow the blood to subsequently be easily separated into the different components is not certain, Gottlieb and Marks write. “But,” they say, “preliminary work shows that achieving something close to the ideal is potentially possible. Such a technology would represent a major public health advance over our current screening tools.”

The statement says CBER is working with a variety of different partners to pursue multiple avenues of research to advance pathogen reduction technology. “We believe perfecting these approaches is a critical priority,” they say.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome